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US5534028: Hydrogel intervertebral disc nucleus with diminished lateral bulging

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Filing Information

Inventor(s) Qi-Bin Bao · Paul A. Higham ·
Assignee(s) Howmedica, Inc. ·
Attorney/Agent(s) Peter C. Richardson ·
Primary Examiner Debra S. Brittingham ·
Application Number US8049820
Filing date 04/20/1993
Issue date 07/09/1996
Predicted expiration date 04/20/2013
U.S. Classifications 623/17  · 606/61  ·
International Classifications A61F 244  ·
Kind CodeA
International Classifications 6238;7;17;16;18;11 ·
4 Claims, No Drawings


Abstract

A prosthetic nucleus for a vertebral disc is made of a hydrogel material. The hydrogel prosthetic nucleus has a shape generally conforming to the natural nucleus pulposus, and it exhibits diminished lateral bulging under high compressive loads. The hydrogel has a water content of from 30% to 90% and has a compressive strength of 4 MNm.sup.-2 or greater. When the hydrogel material is dehydrated, it has a dimension of less than half of that of the hydrated hydrogel nucleus. The prosthetic nucleus may be formed of two or more pieces of hydrogel material which pieces, when combined, have a shape generally conforming to the natural nucleus. The prosthetic nucleus may have a stiff posterior periphery and/or a thickened anterior wall.

Independent Claims | See all claims (4)

  1. 1. A prosthetic nucleus for implanting into a disc space after removal of a degenerated or damaged nucleus of an intervertebral disc, said prosthetic nucleus comprising:a biologically compatible hydrogel material having, when fully hydrated, a size and shape generally conforming to a natural nucleus or to the shape of a cavity created after removal of the degenerated or damaged nucleus; a water content of from about 30% to about 90%; and a compressive strength of about 4 MNm.sup.-2 or greater; and said prosthetic nucleus having a prosthetic nucleus periphery wherein at least part of the prosthetic nucleus periphery exhibits diminished lateral bulging in comparison to other parts of the prosthetic nucleus periphery, wherein said nucleus has a modulus within the range from about 0.1 to about 1.5 MPa, wherein said nucleus has a softest part, and wherein the modulus of the nucleus varies such that at least part of the prosthetic nucleus periphery has a modulus of at least about 10% more than the softest part of the nucleus, wherein the nucleus has an anterior periphery and a posterior periphery, and at least part of the posterior periphery has a modulus of at least about 10% more than the modulus of at least part of the anterior periphery.
  2. 3. A prosthetic nucleus for implanting into a disc space after removal of a degenerated or damaged nucleus of an intervertebral disc, said prosthetic nucleus comprising:a biologically compatible hydrogel material having, when fully hydrated, a size and shape generally conforming to a natural nucleus or to the shape of a cavity created after removal Of the degenerated or damaged nucleus; a water content of from 30% to 90%; and a compressive strength of 4 MNm.sup.-2 or greater; and said prosthetic nucleus having a prosthetic nucleus periphery wherein said nucleus has a modulus within the range from 0.1 to 1.5 MPa, wherein the nucleus has a softest part, and wherein the modulus of the nucleus varies such that at least part of the prosthetic nucleus periphery has a modulus of at least 10% more than the softest part of the nucleus; and wherein the nucleus periphery has a nucleus periphery wall which varies in height by at least 1 mm., wherein the nucleus has an anterior periphery and a posterior periphery, and at least part of the posterior periphery has both (a) a modulus of at least 10% more than the modulus of at least part of the anterior periphery, and (b) a wall thickness of at least 1 mm more than the wall thickness of at least part of the anterior wall.

References Cited

U.S. Patent Documents

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Foreign Patent Documents

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Other Publications

Lee, C. K. et al., "Fiber-Reinforced Functional Disc Prosthesis," 35th Annual Meeting, Orthopaedic Research Society, Feb. 6-9, 1989, Las Vegas, Nevada.
McNally, D. S. et al., "Internal Intervertebral Disc Mechanics as Revealed by Stress Profilometry," Spine, 17, No. 1, pp. 66-73 (1992).
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Patent Family

Document NumberAssigneeInventorsIssue/Pub Date
AU6030294 HOWMEDICA BAO QI-BIN et al. Nov 1994
US5534028 Howmedica, Inc. Qi-Bin Bao et al. Jul 1996
CA2158764 HOWMEDICA BAO QI-BIN et al. Mar 1999
EP0695154 HOWMEDICA INC. Qi-Bin BAO et al. Sep 1999
DE69420402 HOWMEDICA BAO QI-BIN et al. Oct 1999